Investigating sexual health after breast cancer by longitudinal assessment of patient-reported outcomes.

BACKGROUND: Sexual concerns are a major unaddressed need among survivors of breast cancer (BC) with significant negative effects on quality of life. We longitudinally analyzed sexual health over time, using patient-reported outcomes. METHODS: Patients with stage I-III BC prospectively included from the CANcer TOxicity cohort (CANTO) provided data at diagnosis, then 1, 2, and 4 years afterward. Sexual concerns outcomes included poor body image (score ≤91/100), poor sexual functioning (≤16/100), poor sexual enjoyment (≤66/100), and sexual inactivity (EORTC QLQ-B23). Multivariate generalized estimating equation models assessed associations with sexual concerns after diagnosis, adjusting for age, sociodemographic, tumor, treatment, and clinical characteristics. RESULTS: Nearly 78.1% among 7895 patients reported at least one sexual concern between diagnosis and 4 years' follow-up. Over time, the proportion of patients reporting sexual concerns either increased or remained constant with diagnosis. Less than half (46%, range 11.4-57) of the patients with sexual concerns reported the use of supportive care strategies, including gynecological or psychological consultations (range 11.4-57.4). Factors consistently associated with sexual concerns up to 4 years after diagnosis included already reporting the same concern at diagnosis [odds ratio (OR)poor body image 3.48 [95% confidence interval (CI) 3.11-3.89]; ORsexual inactivity 9.94 (95% CI 8.84-11.18), ORpoor sexual function 9.75 (95% CI 8.67-10.95), ORpoorsexual enjoyment 3.96 (95% CI 3.34-4.69)], endocrine therapy use [ORpoor body image 1.15 (95% CI 1.01-1.31); ORsexual inactivity 1.19 (95% CI 1.02-1.39), ORpoor sexual function 1.17 (95% CI 1.01-1.37), ORpoor sexual enjoyment 1.23 (95% CI 1.00-1.53)], and depression [ORpoor body image 2.00 (95% CI 1.72-2.34); ORsexual inactivity 1.66 (95% CI 1.40-1.97), ORpoor sexual function 1.69 (95% CI 1.43-2.00), ORpoor sexual enjoyment 1.94 (95% CI 1.50-2.51)]. Outcome-specific associations were also identified. CONCLUSIONS: Sexual concerns seem frequent, persistent, and insufficiently addressed. Pretreatment concerns, endocrine therapy, and emotional distress are commonly associated factors. A proactive evaluation of sexual health across the care continuum is needed, to promptly identify patients suitable for multidisciplinary counseling, referral, and supportive interventions.

Patient perceptions about obesity management in the context of concomitant care for other chronic diseases.

Background: Approximately 15% of Canadian adults live with two or more chronic diseases, many of which are obesity related. The degree to which Canadian obesity treatment guidelines are integrated into chronic disease management is unknown. Methods: We conducted a 12-min online survey among a non-probability sample of 2506 adult Canadians who met at least one of the following criteria: 1) BMI ≥30 kg/m2; 2) medical diagnosis of obesity; 3) undergone medically supervised treatment for obesity; or 4) a belief that excess/abnormal adipose tissue impairs their health. Participants must have been diagnosed with at least one of 12 prevalent obesity-related chronic diseases. Data analysis consisted of descriptive statistics. Results: One in four (26.4%) reported a diagnosis of obesity, but only 9.2% said they had received medically supervised obesity treatment. The majority (55%) agreed obesity makes managing their other chronic diseases challenging; 39% agreed their chronic disease(s) have progressed or gotten worse because of their obesity. While over half (54%) reported being aware that obesity is classified as a chronic disease, 78% responded obesity was their responsibility to manage on their own. Only 33% of respondents responded they have had success with obesity treatment. Interpretation: While awareness of obesity as a chronic disease is increasing, obesity care within the context of a wider chronic disease management model is suboptimal. More work remains to be done to make Canadian obesity guidelines standard for obesity care.

Factors associated with enrolment in clinical trials among women with early-stage breast cancer.

BACKGROUND: Clinical trials allow development of innovative treatments and ameliorate the quality of clinical care in oncology. Data show that only a minority of patients are enrolled in clinical trials. We assessed enrolment in clinical trials and its correlates among women with early breast cancer. METHODS: We included 9516 patients with stage I-III breast cancer from the multicenter, prospective CANTO study (NCT01993498), followed-up until year 4 (Y4) post-diagnosis. We assessed factors associated with enrolment using multivariable logistic regression. In exploratory, propensity score matched analyses, we used multiple linear regression to evaluate the relationship of enrolment in clinical trials with the European Organisation for Research and Treatment of Cancer Quality Of Life (QoL) questionnaire (EORTC QLQ-C30) Summary Score and described clinical outcomes (distant disease event, invasive disease event, and death by any cause) according to enrolment. RESULTS: Overall, 1716 patients (18%) were enrolled in a clinical trial until Y4 post-diagnosis of breast cancer. Socioeconomic factors were not associated with enrolment. Centres of intermediate volume were most likely to enrol patients in clinical trials [versus low volume, odds ratio 1.45 (95% confidence interval (CI) 1.08-1.95), P = 0.0124]. Among 2118 propensity score matched patients, enrolment was associated with better QoL at Y4 (adjusted mean difference versus not enrolled 1.37, 95% CI 0.03-2.71, P = 0.0458), and clinical outcomes (enrolled versus not enrolled, distant disease event 7.3% versus 10.1%, P = 0.0206; invasive disease event 8.2% versus 10.5%, P = 0.0732; death by any cause 2.8% versus 3.7%, P = 0.2707). CONCLUSIONS: In this large study, one in five patients enrolled on a clinical trial until Y4 after diagnosis of early breast cancer. Geographical and centre-related factors were significantly associated with enrolment in clinical trials. Inclusion in clinical trials seemed associated with improved QoL and clinical outcomes. Access to innovation for early-stage breast cancer patients should be encouraged and facilitated by overcoming organizational and geographical barriers to recruitment.

El índice de pulsatilidad intracraneal elevado apoya el diagnóstico de parkinsonismo vascular frente a enfermedad de Parkinson idiopática / Increased pulsatility index supports diagnosis of vascular parkinsonism versus idiopathic Parkinson's disease

INTRODUCCIÓN: El diagnóstico de parkinsonismo vascular (PV) se realiza en función de una serie de criterios clínicos y hallazgos de neuroimagen compatibles. El aumento en el índice de pulsatilidad (IP) determinado por doppler transcraneal se ha descrito como hallazgo en los pacientes con PV. El objetivo de este trabajo ha sido comprobar en nuestro laboratorio de neurosonología dicha relación y determinar el valor de IP con mayor sensibilidad y especificidad para el diagnóstico de PV. MÉTODO: Se realizó una medición del IP en todos los pacientes remitidos por parkinsonismo al Hospital Universitari I Politècnic La Fe entre enero de 2012 y junio de 2016. En los pacientes finalmente diagnosticados de PV y enfermedad de Parkinson idiopática (EPI) estudiamos la probabilidad de padecer PV en función del valor IP, y elaboramos una curva ROC para determinar el valor de IP con mayor sensibilidad y especificidad. RESULTADOS: Se evaluaron 146 pacientes remitidos por parkinsonismo; 54 (37%) fueron diagnosticados de EPI y 15 (10%) de PV. La media de edad fue mayor en el grupo de PV (79 vs 68,5; p = 0,00144). Encontramos un IP mayor en los pacientes con PV: mediana 1,29 (Q1-Q3: 1,09-1,38) vs 0,96 (Q1-Q3 0,89-1,16), p = 0,01328. En nuestra muestra un valor de IP de 1,09 presenta una sensibilidad y especificidad del 84% y del 70% respectivamente. CONCLUSIONES: En nuestra serie el IP es significativamente mayor en los pacientes con PV que con EPI. Apoyamos la inclusión sistemática del doppler transcraneal en la valoración inicial de pacientes con síndrome rígido-acinético

INTRODUCTION: The diagnosis of vascular parkinsonism (VP) is based on a series of clinical criteria and neuroimaging findings. An increase in transcranial Doppler ultrasonography pulsatility index (PI) has been described as a frequent finding in patients with VP. We aimed to confirm this association and to determine the PI value with the highest sensitivity and specificity for diagnosis of VP. METHOD: PI was determined in all patients admitted to Hospital Universitari I Politècnic La Fe due to parkinsonism between January 2012 and June 2016. We assessed the probability of having VP based on PI values in patients with a definite diagnosis of either VP or idiopathic Parkinson's disease (IPD). A ROC curve was created to determine the PI value with the highest sensitivity and specificity. RESULTS: We assessed a total of 146 patients with suspected parkinsonism; 54 (37%) were diagnosed with IPD and 15 (10%) with VP. Patients with VP were significantly older than those with IPD (mean age of 79 vs 68.5, P = .00144) and had a higher PI (median of 1.29 [IQR: 1.09-1.38] vs 0.96 [IQR: 0.89-1.16], P = .01328). In our sample, a PI of 1.09 conferred 84% sensitivity and 70% specificity. CONCLUSIONS: In our series, the PI was significantly higher in patients with VP than in those with IPD. We therefore support the use of transcranial Doppler ultrasonography for the initial assessment of elderly patients with akinetic-rigid syndrome

Pronóstico de la infección profunda en la cirugía raquídea con implante, tratada mediante retención, retirada del injerto óseo y antibioterapia prolongada / Prognosis of deep infection in spinal surgery using implants, treated by retention, removal of bone graft and lengthy antibiotherapy

Objetivo: La infección profunda de la herida quirúrgica (IPHQ) es una complicación que predispone a un alto riesgo de fracaso en cirugía raquídea con fijación vertebral. El objetivo del presente estudio ha sido valorar la tasa de IPHQ en este tipo de pacientes y su pronóstico siguiendo un abordaje terapéutico homogéneo. Material y método: Estudio observacional retrospectivo en el que se incluyó a 799 pacientes mayores de 14 años, intervenidos de cirugía raquídea con fijación vertebral entre enero de 2010 y diciembre de 2014, en el Servicio de Traumatología y Cirugía Ortopédica de nuestro centro. Todos los pacientes diagnosticados de IPHQ fueron tratados de forma homogénea mediante desbridamiento, sustitución del injerto óseo, retención del implante y tratamiento antimicrobiano de 8 semanas. Tras finalizar el tratamiento, los pacientes fueron seguidos durante un periodo de 12 meses. Resultados: De total de los pacientes tratados mediante artrodesis, 32 (4%) tuvieron una IPHQ. Tres pacientes fueron perdidos en el seguimiento. La muestra final analizable fue de 29 casos, los cuales tenían una mediana de edad de 54,9 años (IQR: 45,7-67 años) y un índice de comorbilidad de Charlson de 2,0 (IQR: 0-3). El diagnóstico microbiológico fue establecido en el 75,8% de los casos. De ellos, la IPHQ fue monomicrobiana en el 68,2% y polimicrobiana en el 31,8%. Con el abordaje terapéutico aplicado curaron sin secuelas el 96% y la tasa de recidivas y reintervención fue del 4%. Conclusión: El tratamiento mediante desbridamiento, retención, sustitución del injerto y tratamiento antimicrobiano de 8 semanas parece una estrategia muy eficaz para los pacientes con fijación vertebral que desarrollan IPHQ

Objective: Surgical site infections (SSIs) are complications that predispose to a high risk of unfavourable surgical outcomes. The aim of this study was to assess the SSI rate in this type of patients and their prognosis with similar treatment. Materials and methods: A retrospective case series of 799 patients above 18 years old with spinal instrumentation surgery, between January 2010 and December 2014 in the traumatology and orthopaedic surgery department of our institution. All patients with SSIs were treated by debridement, graft replacement, retention of the instrumentation and lengthy courses of antimicrobial therapy. The patients were followed up for a period of 12 months. Results: Of all the patients with arthrodesis, 32 (4%) had spinal SSIs. Three patients were lost to follow-up. The final sample analyzed comprised 29 cases, with a median age of 54.9 years (IQR, 45.7-67 years) and a Charlson comorbidity index of 2.0 (IQR; 0-3). A microbiological diagnosis was obtained in 75.8% of the cases. Of these, the ISSs were monomicrobial in 68.2% and polymicrobial in 31.8%. Once treatment had been completed, 96% were cured without sequelae, and the rate of recurrence and reoperation was 4%. Conclusions: Treatment based on debridement, retention of the instrumentation, graft replacement and lengthy courses of antimicrobial therapy seems a very effective strategy in the treatment of patients with deep surgical site infection in spine surgery

UNICANCER-PEGASE 07 study: a randomized phase III trial evaluating postoperative docetaxel-5FU regimen after neoadjuvant dose-intense chemotherapy for treatment of inflammatory breast cancer.

BACKGROUND: Inflammatory breast cancer (IBC) is a rare and aggressive disease requiring a multimodal treatment. We evaluated the benefit of adding docetaxel-5-fluorouracil (D-5FU) regimen after preoperative dose-intense (DI) epirubicin-cyclophosphamide (EC) and locoregional treatment in IBC patients. PATIENTS AND METHODS: PEGASE 07 was a national randomized phase III open-label study involving 14 hospitals in France. Women with nonmetastatic IBC were eligible and randomly assigned to receive either four cycles of DI EC (E 150 mg/m(2) and C 4000 mg/m(2) every 3 weeks with repeated hematopoietic stem cell support), then mastectomy with axillary lymph node dissection, and radiotherapy (arm A) or the same treatment followed by four cycles of D-5FU (D 85 mg/m(2), day 1 and 5FU 750 mg/m(2)/day continuous infusion, days 1-5 every 3 weeks) administered postradiotherapy (arm B). Patients with hormone receptor-positive tumors received hormonal therapy. Disease-free survival (DFS) was the primary end point. Secondary end points included tolerance, pathological complete response (pCR) rate, and overall survival (OS). RESULTS: Between January 2001 and May 2005, 174 patients were enrolled and treated (87 in each arm). Median follow-up was similar in both arms: 59.6 months [95% confidence interval (CI) 58.4-60.3] in arm A and 60.5 months (95% CI 58.3-61.4) in arm B. The estimated 5-year DFS rates were not different: 55% (95% CI 43.9-64.7) in arm A and 55.5% (95% CI 44.3-65.3) in arm B [hazard ratio (HR) = 0.94 (0.61-1.48); P = 0.81]. Identical results were observed for 5-year OS: 70.2% (95% CI 59.1-78.8) in arm A and 70% (95% CI 58.8-78.7) in arm B [HR = 0.93 (0.55-1.60); P = 0.814]. Following DI EC induction, in-breast and global (breast plus nodes) pCR were 28.9% and 20.1%, respectively. Estrogen receptor and pCR status were independently associated with survival. CONCLUSION: The addition of D-5FU after preoperative DI EC and standard local therapy did not improve DFS in IBC. CLINICAL TRIAL NUMBER: ClinicalTrials.gov identifier: NCT02324088.

Participants' uptake of clinical trial results: a randomised experiment.

BACKGROUND: Participants are showing great interest these days in obtaining the results of clinical trials. The aim of this study was to assess patients' uptake and understanding of the results of the trial in which they have participated and the impact of a letter offering patients the possibility of consulting the trial results on a specific website. METHODS: Breast cancer patients participating in a trial on the efficacy of Trastuzumab were randomly subdivided into an Internet group (who received the letter of invitation) and a control group (who did not receive it). Among 115 HER2-positive women from 21 centres, 107 (93%) answered a self-administered questionnaire. RESULTS: Most of the patients in both groups had access to the Internet (72.0%). The majority (97.2%) stated that receiving information about the trial results would be useful, and the oncologist was the most frequently preferred information provider. The Internet group's declared uptake of the trial results was only slightly higher (47.1% vs 33.9%; P=0.166); however, they understood the results significantly more accurately (18.8% vs 5.6%; P=0.039). INTERPRETATION: Although Internet was not the respondents' preferred source of information, the possibility of using this source slightly increased the uptake and understanding of the results.

Cost-effectiveness of adjuvant docetaxel for node-positive breast cancer patients: results of the PACS 01 economic study.

BACKGROUND: Using data from the PACS 01 randomized trial, we evaluated the cost-effectiveness of anthracyclines plus docetaxel (Taxotere; FEC-D) versus anthracyclines alone (FEC100) in patients with node-positive breast cancer. PATIENTS AND METHODS: Costs and outcomes were assessed in 1996 patients and the incremental cost-effectiveness ratios (ICERs) were estimated, using quality-adjusted life years (QALYs) as outcome. To deal with uncertainty due to sampling fluctuations, confidence regions around the ICERs were calculated and cost-effectiveness acceptability curves were drawn up. Sensitivity analyses were also carried out to assess the robustness of conclusions. RESULTS: The mean cost of treatment was 33% higher with strategy FEC-D, but this difference decreased to 18% at a 5-year horizon. The ICER of FEC-D versus FEC100 was estimated to be 9665euro per QALY gained (95% confidence interval euro2372-euro55 515). The estimated probability that FEC-D was cost-effective reached >96% for a threshold of euro50 000 per QALY gained. If the price of taxane decreased slightly, the ICER would reach some very reasonable levels and this strategy would therefore be much more cost-effective. CONCLUSION: The sequential use of FEC100 followed by docetaxel appears to be a cost-effective alternative, even when uncertainty is taken into account.

Mobbing: una propuesta exploratoria de intervención / Mobbing: An exploratory proposal for intervention

Mobbing or harassment at work, is a continued and incremental process that undergoes the person because reiterated negative conducts by his/her superiors or equal ones in the labour environment. The effects, which are produced on the person both emotional and psychosomatic levels, are not detected in the beginning, causing a deterioration of the person well-being in the long term. Indeed, when mobbing appears, processes of absenteeism, losses and turn over begin to take place, these issues could have palliate effects in the beginning, but in the long run if they are not abashed and confronted, could end in a deep malaise situation. This labour environmental upheaval must be undertaken with the aim to provide protocols of prevention, detection and treatment that minimize the costs they produce not only in the management but also in the personal level. In the present work it has been developed and applied a registered group program (9 sessions), which has obtained positive results, equipping the subjects for mechanisms in the recovery of their personal well-being, improving their levels of anxiety, depression, modifying their negative thoughts and carrying out a positive problem facing (AU)

El mobbing o “acoso moral en el trabajo”, es un proceso continuado e incremental que sufre la persona ante las conductas negativas reiteradas por parte de sus superiores o iguales en el entorno laboral. Los efectos que produce en la persona tanto a nivel emocional como psicosomático, no son detectados al inicio, es más, se van acumulando provocando un deterioro del bienestar de la persona a largo plazo. Además, cuando aparece el mobbing, comienzan a producirse procesos de absentismo, bajas laborales y rotaciones, que en principio pueden paliar los efectos, pero a la larga si no se atajan y afrontan, puede acabar en una situación de profundo malestar. Este trastorno que sucede en el entorno laboral, debe ser acometido con el fin de proporcionar protocolos de prevención, detección y tratamiento que minimecen los costes producidos tanto a nivel empresarial como personal. En el presente trabajo se ha desarrollado y aplicado un programa grupal protocolizado (9 sesiones), que ha obtenido resultados positivos al dotar a los sujetos de mecanismos para la recuperación de su bienestar personal, mejorando sus niveles de ansiedad, depresión, modificando los pensamientos negativos y realizando un afrontamiento positivo de los problemas (AU)

Estudio de las causas de abandono del tratamiento en un centro de atención a drogodependientes / Study of the causes for abandoning treatment in a drug addict care center

Objetivo. Explorar las razones por lascuales los pacientes interrumpen voluntariamentesu tratamiento de la adicción.Material y métodos. Se selecciona el 25% (n = 53)de los abandonos de tratamiento en un período de15 meses (n = 213) en un centro público de atencióna drogodependencias (CAD-4, Ayuntamiento deMadrid). Se contacta telefónicamente y se preguntanlas causas por las cuales dejó de acudir a las citasclínicas.Resultados. Se contactó con 31 personas que accedierona responder a la entrevista. De ellas, el 29%alegaron no requerir más tratamiento por haberalcanzado sus objetivos, el 32,3% incompatibilidadcon el trabajo o cambio de domicilio, el 22,6% deficienciasen el servicio y 9,7% falta de motivación para seguir las pautas del tratamiento.Conclusiones. Sorprende el hecho de que casi untercio de la muestra dé por terminado el tratamientoal haber alcanzado un éxito no ratificado por losprofesionales. Se discute la pertinencia de los criterioshabitualmente manejados por los profesionalespara estimar la consecución del éxito de los tratamientosy la necesidad de atender los criterios de lospacientes, acaso no tan exigentes como los establecidoshabitualmente por los programas de rehabilitación.Se propone un seguimiento más estrecho de losabandonos para conocer sus causas, recuperar alos pacientes o establecer criterios de éxito másajustados a la realidad

Objective. To explore reasons by whichthe patients voluntarily interrupt their addictiontreatment.Material and methods. Its selects 25% (n = 53) ofdesertions in 15 months (n = 213) in a publicly fundedCenter of Treatment to Drug-Dependencies(CAD-4, Madrid City Council, Spain). They were contacted by telephone and the causes for which they give up the clinical sessions are asked.Results. Thirty one persons were contacted andacceded to respond to the interview. From them, 29% alleged not to need more treatment because they have reached their objectives, 32.3% incompatibilitywith job or change of address, 22.6% deficienciesin service and 9.7% lack of motivation to follow the guidelines of the treatment.Conclusions. Surprisingly, third part of sampleconsider finished their treatment successfully inspite of professional criteria. Relevance of criteriahabitually handled by professionals is discussedto consider success of treatments and the necessityto consider patients criteria, perhaps not as demanding as the established ones habitually by rehabilitation programs. A closer pursuit of the attrition sets out to know its causes, to recover the patients or to establish success criteria more fit to the reality